Teruma Recalls Coronary Ostia Cannulas

The Terumo Coronary Ostia Cannula 10, 12, 14, indicated for use in delivering cardioplegia solution directly to the coronary arteries during cardiopulmonary bypass, has been recalled, the U.S. Food and Drug Administration (FDA) just announced.

The Terumo Coronary Ostia Cannula is indicated for use in delivering cardioplegia solution directly to the coronary arteries during cardiopulmonary bypass.

Foreign fragments of adhesive and plastic in the cannula tip may embolize causing arterial injury, hemorrhaging, or other serious events requiring unplanned surgery.

Terumo Cardiovascular Systems Corporation (Terumo CVS) decided to remove the product line from the market and discontinue further supply, issuing a recall.

The recall was designated a Class I by the FDA. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Terumo is advising customers to immediately discontinue use of any affected product and return all products in inventory. All lot/serial numbers of the Coronary Ostia Cannula 10 (25 cm) long, model numbers 804115, 804117, 804159 are being recalled; 6,220 devices are subject to this recall.

The company notified customers by letter on May 16, 2011 describing the problem, the potential hazard, and the action to be taken. Customers were instructed to discontinue use and return all products to Terumo CVS.

The recall was issued by Terumo Cardiovascular Systems Corporationâ€¨at 6200 Jackson Road,â€¨Ann Arbor, Michigan, 48103. Its customer service department can be reached, toll-free, from 8:00 a.m. to 6:00 p.m., Monday through Friday, at 1.800.521.2818.

Health care professionals and consumers may report adverse reactions or quality problems when using these products to FDAâ€™s MedWatch Adverse Event Reporting program either online, by regular mail, or by FAXL Complete and submit the report online at www.fda.gov/MedWatch/report.htm; download the form at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm or call 1.800.332.1088 to request a reporting form. Complete and return the form to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.